NCT00693680

Brief Summary

Examination of the effect of zinc supplementation on imipramine therapy in major depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

1.2 years

First QC Date

June 5, 2008

Last Update Submit

June 9, 2008

Conditions

Major Depression

Keywords

depressionantidepressant treatmentzincplacebo

Outcome Measures

Primary Outcomes (1)

  • To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)

    12 weeks

Secondary Outcomes (1)

  • To assess unwanted side effects in both groups

    12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

zinc + imipramine

Dietary Supplement: Zincas Forte

2

PLACEBO COMPARATOR

placebo + imipramine

Dietary Supplement: Placebo

Interventions

Zincas ForteDIETARY_SUPPLEMENT

25 mgZn/day + imipramine (100-200mg/day)

Also known as: Zincas Forte (Farmapol, Poland), Imipramin (Polfarma, Poland)
1
PlaceboDIETARY_SUPPLEMENT

placebo + imipramine (100-200mg/day)

Also known as: Imipramin (Polfarma, Poland)
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
  • one week washout period without any pharmacotherapy

You may not qualify if:

  • psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Collegium Medicum, Jagiellonian University

Krakow, 31-501, Poland

Location

Related Publications (1)

  • Nowak G, Siwek M, Dudek D, Zieba A, Pilc A. Effect of zinc supplementation on antidepressant therapy in unipolar depression: a preliminary placebo-controlled study. Pol J Pharmacol. 2003 Nov-Dec;55(6):1143-7.

    PMID: 14730113BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Andrzej Zieba, Prof.

    Department of Psychiatry, Collegium Medicum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

PL(1)